MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

It was reported that the patient had a lot of problems with the stimulator.The patient was at the mayo clinic trying to get assistance but the patient planned to wait to make changes on settings until they went back home.The patient was having jolts/electric shocks going through their body.The setting would go from 2.7v to 3.6v and it would reset itself.They could not figure out what was going on.The patient used their programmer to turn off stimulation and then turned it back on.They adjusted to 2.7v and waited 3 minutes, sitting still.They would walk away and then it would all of a sudden jolt the patient and the programmer would go back to 3.6v.The patient was on group d at 3.6v to 3.7v.The patient was advised to decrease the setting and stay in that position for 3 minutes so the device would remember the setting.It was noted that ¿mobile¿ may not be available and the patient would need to see a physician who could use their clinician programmer to make the setting more sensitive to mobile.The patient was reminded that they would need to sync to refresh setting.Additional information about any further troubleshooting and outcome was requested.If received a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient; product id 97754, serial# (b)(4), product type: recharger; product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4487536
• MDR Text Key: 17219951
• Report Number: 3004209178-2015-01825
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2015
• Date Device Manufactured: 01/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00071 YR